Glabellar Frown LinesPhase 3NCT05146999
Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines
A Phase 3 study testing QM1114-DP in people with Glabellar Frown Lines, run by Galderma R&D at 9 sites in United States.
Trial summary
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- QM1114-DP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 May 2022to 1 Sep 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female 18 years or older
- Moderate to severe GL at maximum frown as assessed by the Investigator
- Moderate to severe GL at maximum frown as assessed by the subject
Who cannot join
- Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
- Female who is pregnant, breast feeding or intends to conceive a child during the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Galderma Research Site
Chapel Hill, North Carolina, 27517
Galderma Research Site
Coral Gables, Florida, 33146
Galderma Research Site
Homewood, Alabama, 35209
Galderma Research Site
Hunt Valley, Maryland, 21030
Galderma Research Site
Manhattan Beach, California, 90266
Galderma Research Site
Omaha, Nebraska, 68144
Galderma Research Site
Pflugerville, Texas, 78660
Galderma Research Site
Spring, Texas, 77388
Galderma Research Site
Vista, California, 92083
About this study
Official title: A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
- Conditions
- Glabellar Frown Lines
- Being tested
- QM1114-DP, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QM1114-DPBiological
QM1114-DP
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active arm - QM1114-DP | Active comparator | a Botulinum Toxin Type A (BoNT-A) Receives: Biological: QM1114-DP |
| Inactive arm - Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).
Measured: At Month 1
Secondary outcomes (2)
Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card
Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond "yes" or "no" to the following question: "Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown?" Response to treatment effect given by a Participant on first day as "yes" to the diary question.
Measured: At Days 0 through 7 post-treatment
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12
Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded "improved," "much improved," or "very much improved" on the GAIS at maximum frown. This analysis is based on observed cases.
Measured: From Day 1 through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start9 May 2022
- Primary completion28 Oct 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146999
- Sponsor's protocol ID
- 43QM2106
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2021
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05146999
- Acronym / sponsor ID
- 43QM2106
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Active arm - QM1114-DP | Active comparator | Biological: QM1114-DPa Botulinum Toxin Type A (BoNT-A) |
| Inactive arm - Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female 18 years or older
- Moderate to severe GL at maximum frown as assessed by the Investigator
- Moderate to severe GL at maximum frown as assessed by the subject
Key exclusion criteria (2 listed)
- Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
- Female who is pregnant, breast feeding or intends to conceive a child during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QM1114-DPQM1114-DP | Biological | Active arm - QM1114-DP |
| PlaceboPlacebo | Biological | Inactive arm - Placebo |
Primary outcome
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
Time frame: At Month 1
Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).
2 secondary outcomes
Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card
Time frame: At Days 0 through 7 post-treatment
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12
Time frame: From Day 1 through Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QM1114-DP in people with Glabellar Frown Lines, run by Galderma R&D at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 (time frame: At Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.